What is the initial approach to prescribing digestive enzymes, such as Creon (pancrelipase), for patients requiring supplementation?

Prescribing Digestive Enzymes: Initial Approach

Pancreatic enzyme replacement therapy (PERT) should be initiated with enteric-coated microsphere preparations at a minimum lipase dose of 20,000-50,000 PhU with main meals and half that dose with snacks, taken at the beginning of or during meals. 1

Diagnosis and Patient Selection

When considering PERT, first identify patients with exocrine pancreatic insufficiency (PEI) through:

• Clinical symptoms: steatorrhea, weight loss, flatulence, bloating, dyspepsia, abdominal pain, and urgent bowel movements 1
• Laboratory evidence: fecal fat >7-15g/day or coefficient of fat absorption <80% 1
• Nutritional markers: low albumin, prealbumin, retinol-binding protein, magnesium 1

Medication Selection

Choose from FDA-approved formulations:

Brand	Type	Available lipase strengths (USP)
Creon	Enteric-coated microspheres	3,000/6,000/12,000/24,000/36,000
Zenpep	Enteric-coated beads	3,000/5,000/10,000/15,000/20,000/25,000/40,000
Pancreaze	Enteric-coated microtablets	2,600/4,200/10,500/16,800/21,000/37,000
Pertzye	Enteric-coated microspheres	4,000/8,000/16,000/24,000
Viokace	Non–enteric-coated tablets	10,444/20,880

1

Initial Dosing Algorithm

1. Standard starting dose:

   • 20,000-50,000 PhU lipase with each main meal
   • 10,000-25,000 PhU lipase with snacks 1

2. Administration timing:

   • Take at the beginning of or during meals
   • For multiple capsules, spread throughout the meal 1
   • For older non-enteric coated preparations (rarely used): take 1/3 before, 1/3 during, and 1/3 after meals 1

3. Dosage adjustments:

   • Individualize based on:
     • Meal fat content (higher fat = higher dose)
     • Severity of pancreatic insufficiency
     • Clinical response 1

Monitoring Efficacy

Evaluate treatment success through:

1. Clinical response:

   • Reduction in steatorrhea and GI symptoms
   • Weight gain
   • Improved nutritional status 1

2. Laboratory parameters:

   • Fat-soluble vitamin levels (A, D, E, K)
   • Nutritional markers (prealbumin, retinol-binding protein)
   • Consider fecal fat testing if clinical response is inadequate 1

3. Follow-up timing:

   • Initial follow-up: 2-4 weeks after starting therapy
   • Stable patients: at least annual assessment 1

Special Considerations

1. Diabetic patients:

   • Monitor blood glucose closely when starting or adjusting PERT
   • Improved nutrient absorption may significantly alter insulin requirements
   • Consider in-hospital supervision for insulin-dependent diabetics when initiating therapy 2

2. Enteral feeding:

   • For gastric tubes: Open capsules and suspend microspheres in thickened acidic fluid
   • For jejunal tubes: Crush microspheres, activate with sodium bicarbonate, then flush into tube
   • Consider specialized products like Relizorb for enteral feeding formulas 1, 3

3. Treatment failures:

   • If inadequate response despite proper dosing, consider:
     • Adding proton pump inhibitor or H2 blocker
     • Evaluating compliance
     • Reassessing diagnosis
     • Checking for small intestinal bacterial overgrowth 1

Pitfalls to Avoid

1. Underdosing: Most common reason for treatment failure - don't hesitate to increase dose in adults as there is no upper limit (excess enzymes are eliminated in stool) 1

2. Poor timing: Enzymes must be taken with meals to be effective 1

3. Inappropriate formulation: Always use enteric-coated preparations except in specific circumstances (non-enteric coated forms are less effective due to gastric acid inactivation) 1, 4

4. Neglecting nutritional assessment: Regular monitoring of nutritional status is essential for optimal outcomes 1

5. Ignoring bone health: Obtain baseline DEXA scan and monitor bone density every 1-2 years 1